Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy

NCT05972304 | Completed

• 1 other identifier: EndoBreath
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key components and factors, which lead to development of hypercarbia during endoscopy.

Conditions

Hypercapnia; Hypoxia

Outcome Measures

Primary Outcomes (2)

• Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure

  During endoscopic procedure

• Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure

  During endoscopic procedure

Secondary Outcomes (4)

• Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups

  During endoscopic procedure

• Number of desaturation episodes (SpO2 < 90%)

  During endoscopic procedure

• Interception of the intervention due to insufficient oxygenation

  During endoscopic procedure

• The emmergence of serious adverse events

  During endoscopic procedure

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).

Device: Nasal positive airway System by Vyaire Medical

Control Group

NO INTERVENTION

Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute).

Interventions

Nasal positive airway System by Vyaire Medical DEVICE

Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor

Also known as: Superno2Va, Radiometer TCM 5

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (\>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents)
• ASA IV (recent (\<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis
• Active Malignancy (ECOG Performance \>2)

You may not qualify if:

• Patients with tracheotomy
• Pregnancy
• Intubation assisted endoscopy
• Procedure without sedation

Sponsors & Collaborators

• University of Ulm: lead

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Hypercapnia; Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Benjamin Walter

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: August 2, 2023
• Study Start: April 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)